Universal T-cell therapy for treating severe aGVHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the safety and effectiveness of engineered universal T-cells with chimeric natural killer receptors (CNK-UT) in patients suffering from steroid-refractory or steroid-dependent acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation. It is a single-arm, open-label, multi-center trial that aims to assess pharmacokinetics and pharmacodynamics of the treatment. Participants will receive the CNK-UT therapy and will be monitored for their response and any adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 14-70 years, male or female;
2. Participants diagnosed with grade II\~IV steroid-refractory/resistant or steroid-dependent aGVHD after allogeneic hematopoietic stem cell transplantation.
3. ECOG physical status score 0\~3;
4. Estimated life expectancy \> 12 weeks;
5. Female participants of childbearing age must undergo a serum or urine pregnancy test before enrollment, and the results must be negative, and agree to take acceptable measures to minimize the possibility of pregnancy during the trial; For female participants of childbearing age or male participants whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the study and for at least 6 months following the last dose of the study cells infusion.
6. Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.

Exclusion Criteria:

1. Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and / or radical resection of carcinoma in situ.
2. Participants with a history of organ transplantation;
3. Participants who have previously undergone more than one allogeneic hematopoietic stem cell transplantation.
4. Uncontrolled hypertension as determined by principal investigator, a history of hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart failure (New York Heart Association classification III-IV); symptomatic or poorly controlled arrhythmias; a history of congenital long QT syndrome or a corrected QT interval (QTc) \> 500 ms at screening (calculated using the Fridericia method)..
5. Systemic diseases deemed unstable by principal investigator include, but are not limited to, severe pulmonary, hepatic, renal, or metabolic disorders that require pharmacological intervention (excluding complications related to allogeneic hematopoietic stem cell transplantation).
6. Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis infection.
7. Severe infections that are active or poorly controlled clinically.
8. Participants who have received treatment from other clinical trials within 12 weeks prior to the initiation of the study.
9. Participants who have previously used any gene therapy products prior to the initiation of the study.
10. Allergic to components of CNK-UT injection.
11. Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.
12. Women who are pregnant or breastfeeding, as well as male or female participants who have planned for birth within 1 year after receiving medication.
13. Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and/or uncertainty in survival assessments.
14. Other situations that the participant is identified by the investigator as unsuitable to participate in the study.

Where it's running

• First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• The first affiliated hospital of zhejiang university, school of medicine.
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: He Huang, PHD — First Affiliated Hospital of Zhejiang University
• Study coordinator: Li Luo, MD
• Email: luoyijr@zju.edu.cn
• Phone: +860571-87233801

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• Post-transplant dental cleaning to prevent chronic graft-versus-host disease

  This will try a dental cleaning about 28 days after an allogeneic stem cell transplant to see if it lowers the chance of chronic graft-versus-host disease in adult transplant recipients.

  Recruiting Fred Hutchinson Cancer Center · Seattle, Washington · NCT07535008

• First-line jaktinib plus corticosteroids for acute graft-versus-host disease

  This trial will test whether adding jaktinib to standard steroids helps adults with grade II–IV acute graft-versus-host disease after an allogeneic stem cell transplant.

  Recruiting Phase 1/2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07285889

• Timing of umbilical cord blood infusion and risk of acute graft-versus-host disease after transplant

  This trial will test whether giving a single-unit unrelated umbilical cord blood transplant at different times of day changes the chance of acute graft-versus-host disease in people with malignant blood disorders who are in remission.

  Recruiting Phase 3 Anhui Provincial Hospital · Hefei, Anhui · NCT07047456

• Ruxolitinib treatment for acute graft-versus-host disease

  This study is testing if ruxolitinib can help people with acute graft-versus-host disease who haven't improved with regular steroid treatments.

  Recruiting at 10 sites Phase 2 Icahn School of Medicine at Mount Sinai · Duarte, California and 13 other locations · NCT06936566

• Using human chorionic gonadotropin to treat acute graft versus host disease

  This study is testing if adding a hormone called hCG to standard steroid treatment can help people with acute graft versus host disease feel better after their stem cell transplant.

  Recruiting Phase 2 Hospital Universitario Dr. Jose E. Gonzalez · Monterrey, Nuevo León · NCT06904599

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.